There is a critical need for clinical research on treatment of acute neurological conditions such as traumatic brain injury, status epilepticus, and stroke. NINDS and NIH have committed to this research through support of the Neurological Emergencies Treatment Trial (NETT) group and other studies addressing these important public health threats. Despite the ethical imperative to conduct these studies, other ethical challenges, particularly the inability to obtain patient consent in many emergencies, have posed significant barriers to research. Federal regulations permit an exception from informed consent (EFIC) in emergency settings, but many institutions and investigators have little experience with EFIC research, the regulations themselves are controversial and ambiguous, and there remains disagreement about when such studies are appropriate (1-4). Furthermore, media controversy and uncertainty about public views of EFIC research have prompted concern about the potential reactions of patients and their families to inclusion in studies without consent (5;6). This project, entitled "Patients'Experiences in Emergency Research (PEER)," responds directly to the NIH request for research on challenges to informed consent and to the NINDS request for research specifically addressing challenges in EFIC research. PEER will, for the first time, assess the experiences and views of patients enrolled in an EFIC study. Existing data conflict regarding support for EFIC research among the general public and among persons affected by conditions likely to be the subject of EFIC research (7-11), and no study has ever assessed the views of patients actually enrolled in an EFIC study. Understanding enrolled patients'experiences and views will provide benchmarks for expected levels of support in EFIC studies, bring to light concerns of this most important population, identify strategies for improving the experience of enrollment in EFIC studies, and provide an assessment of the impact and effectiveness of the community consultation and public disclosure efforts required by regulations. The PEER study will represent the first systematic assessment of the experiences and views of subjects enrolled in an EFIC study. It will involve conducting semi-structured interviews with patients included in RAMPART, an NINDS-funded study conducted within the NETT and evaluating pharmacologic treatment of status epilepticus by EMS personnel. PEER will include patients at each of 5 diverse sites and will capitalize on expertise regarding EFIC research among NETT investigators and the presence of concurrent ethics projects within NETT. Specific aims include: assessing enrolled patients'views of RAMPART and their enrollment in it;assessing enrolled patients'views of EFIC research generally and their enrollment in an EFIC study;identifying reasons for and predictors of views;and assessing the impact and effectiveness of major regulatory protections. This project represents an integral component of the effort to advance understanding of the ethics of EFIC research in order to facilitate important studies while respecting enrolled patients. PUBLIC HEALTH RELEVANCE: Severe, acute neurological conditions such as stroke, traumatic brain injury, and status epilepticus, represent major causes of morbidity and mortality in the Unites States, and clinical research is essential to improving often ineffective or poorly studied treatments for these important public health threats. However, this important research is often complicated and impeded by ethical challenges and controversy surrounding the enrollment in clinical trials of emergently ill patients who are unable to provide consent for research participation. The "Patients'Experiences in Emergency Research (PEER)" project will advance the NIH goal of facilitating the ethical conduct of much-needed clinical research by soliciting, for the first time, the views and experiences of patients enrolled without consent in a randomized controlled trial of pre-hospital treatment of status epilepticus.